SBIR grant support is being sought by 20/20 GeneSystems, Inc. (20/20), a small biotech company, to help us advance what we believe will become the first blood test to be routinely employed to aid in the early detection of head and neck cancer. Despite recent advances in both diagnostic and therapeutic modalities, long-term prognosis for patients affected by advanced stage head and neck squamous cell carcinoma (HNSCC) remains dismal with 5-year survival less than 40%. This grim prognosis is in distinct contrast to the more than 80% chance of cure for those patients who present with early stage cancer. Unfortunately, more than two-third of patients with HNSCC are diagnosed only after the disease is advanced. Failure to diagnose this cancer early is mainly attributed to the unavailability of a screening test for high risk patients as well as frequent misdiagnosis of early stage cancer by primary physicians. An autoantibody immunoassay for head and neck squamous cell carcinoma (HNSCC) is expected to become a novel non-invasive tool for early diagnosis. Our long term strategy, which would become the subject of a Phase II SBIR grant application should Phase I work be successful, is to develop a "tobacco user's chip" to screen for both HNSCC and lung cancer in one blood sample, because current and former smokers are at high risk for both diseases. The serological test should have a significant impact on the quality of medical care for persons at risk, particularly for over 20% of the US population who are users of tobacco and/or alcohol products. PUBLIC HEALTH RELEVANCE: A blood test for early detection of head and neck cancer could provide a cost-effective screening approach when applied to presently known high risk groups, who are: users of tobacco and/or alcohol, the immune-compromised, and those with premalignant lesions. It would enable a viable strategy for reducing the severe mortality rate of this disease.